Efficacy and safety of polyherbal formulation as an add-on to standard-of-care in mild-to-moderate COVID-19: A randomized, double-blind, placebo-controlled trial.

Background: Novel corona virus disease-2019 (COVID-19) pandemic is a significant contributor to morbidity and mortality in affected individuals. Modulating the immune response in COVID-19 is now an established treatment approach. Polyherbal formulations have long been assessed for their potential immune modulating effects and are expected to be beneficial on COVID-19. Methods: This study aims at assessing the efficacy and safety of polyherbal formulation (referred as IP) in comparison to placebo, as add on to the standard of care (SOC), in patients with mild to moderate COVID-19 patients. Hospitalized RT-PCR positive patients were randomized to either SOC + IP or SOC + Placebo arm. The viral load (VL) was assessed using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Immunological parameters were also assessed. The clinical improvement was assessed using a numeric rating scale (NRS) and WHO ordinal scale, and follow-up period was 30 days. Results: Seventy-two patients were randomized to SOC + IP (n = 39) and SOC + Placebo (n = 33) arms. There was significant reduction in VL in SOC + IP arm from day 0-4 (p = 0.002), compared to SOC + Placebo arm (p = 0.106). Change in the NRS score and WHO score was significant in both arms, however, the difference between the two arms was statistically significant in favour of IP arm. The increase in Th1 response was significant in SOC + IP arm (p = 0.023), but not in SOC + Placebo arm. COVID-19 specific antibodies were numerically higher in the SOC + IP arm. Conclusion: The study finds that polyherbal formulation significantly reduces VL and contributes to immunomodulation and improvement in clinical conditions without side effects.

Harlequin fetus: A case report.

Harlequin ichthyosis (HI) is the most severe type of congenital ichthyosis. It is extremely rare with very few cases reported in India. It is inherited in an autosomal recessive fashion. The importance of antenatal diagnosis by ultrasonography, DNA-based molecular studies on chorionic villus sampling, and amniocentesis has been emphasized. We report a new case of HI in an infant, diagnosed postnatally by correlation of clinical and histopathological features on skin biopsy. The infant succumbed on the second day of birth despite intensive supportive care. A short review of the literature regarding the condition is also presented.

Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: Primary Objective • To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection. Secondary Objectives • To assess the efficacy of herbal extracts in restoring respiratory health • To assess the efficacy of Cap. IP in early recovery of patients and decline in viral load • To assess the safety of herbal extracts TRIAL DESIGN: This is a single centre, randomized, 2-arm, parallel group, double blind, 1:1 ratio, controlled, exploratory trial with a study period of 30 days from the day of enrolment. PARTICIPANTS: Patients attending the COVID treatment centre at Yashwantrao Chavan Memorial Hospital, Nehrunagar, Pimpri, Pune, India were screened for their participation in the study. Patients who were known COVID-19 positive (with positive RT-PCR), eligible and willing were enrolled in the study. INTERVENTION AND COMPARATOR: The intervention in the trial has a background in 'Ayurved'. Intervention Arm: Two capsules, Investigational Product (IP) - 1 - 400mg and Investigational Product - 2 - 450mg, containing herbal extracts (a blend of water and CO2 extracts) of Shunthi (Zingiber officinale (Ginger), Vidanga (Embelia ribes), Yashtimadhu (Glycyrrhiza glabra), Haritaki (Terminalia chebula), Guduchi (Tinospora cordifolia), Shatavari (Asparagus racemosus), Aamalaki (Emblica officinalis), Pippali (Piper longum) and calcined Zinc, Shankha bhasma. Placebo Arm: Edible starch ~ 450 mg. The look and feel of IP and of Placebo boxes were very similar. Patients are to take two capsules (one each of IP-1 and IP-2) twice a day for 15 days, and from the 16th day, one capsule of IP-2 twice a day up-to day 30. Capsules are to be administered orally with plain water. The IP is to be taken with all other concomitant medicines prescribed by the treating physician/doctor. The dose of each component in the IP is very safe to administer. The investigational products are registered products with the Indian Government and have been used for more than 6 months in various health conditions but not for COVID-19. MAIN OUTCOMES: Primary Outcome: Efficacy of the herbal extracts in COVID 19 positive patients (in declining viral load: time-point: 4 days and early recovery) Secondary Outcomes: Efficacy of the herbal extracts as an immune-modulator - TH1, TH2, Th17, IL6, NK Cells and CD markers; Immunoglobulin IGG (Serum); Immunoglobulin IGM (Serum) - at 30 days. Efficacy of the investigational product in reducing sequela of the disease Safety analysis (Liver Function Test and Kidney Function Test) including serious allergic reaction of: rash, itching/swelling, severe dizziness, trouble breathing. RANDOMISATION: An alphanumeric coded set of IP/Placebo containers will be used. Participants will be automatically randomized to two groups in the ratio 1:1. BLINDING (MASKING): Participants, caregivers and investigators were blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of more than 60 and up to 75 patients were to be enrolled in the study into the two groups, considering drop-outs. 72 were enrolled with 37 into the intervention group and 35 into the placebo group. TRIAL STATUS: Protocol number: CoviQuest-01 Protocol version number: 1.2 Protocol Date: 1st July 2020 The recruitment period is completed for the trial. Date of 1st patient enrolment was 11th Aug 2020 and the last patient was enrolled on 3rd of September 2020. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Last Participant's last follow-up is scheduled on 5th October 2020 TRIAL REGISTRATION: The trial was prospectively registered with the CTRI (Clinical Trial Registry of India). Registration number is CTRI/2020/07/026570 . Registered on 14 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Congenital Lobar Emphysema with Pulmonary Extramedullary Hematopoiesis.

Congenital lobar emphysema is a one of the rare variety of congenital abnormality of the lung causing respiratory distress in newborns and infants. Herein, we report a case of congenital lobar emphysema in a 3-week-old female admitted to the pediatric intensive care unit with severe respiratory distress. CT scan revealed a hyperinflated, hyperlucent left upper lobe, collapse of the ipsilateral lung and marked mediastinal shift to the right. The patient underwent emergency left upper lobectomy with improvement of her condition in the postoperative period. Histopathological findings confirmed the clinical diagnosis of congenital lobar emphysema with an unusual finding of pulmonary extramedullary hematopoiesis. Congenital lobar emphysema often presents a diagnostic and therapeutic dilemma and therefore requires a high index of suspicion in neonates presenting with respiratory distress to avoid morbidity and mortality.

Primary Spindle Cell Malignant Melanoma of Esophagus: An Unusual Finding.

Malignant melanoma of esophagus is usually a metastatic tumour rather than a primary tumour. Primary malignant melanoma accounts for less than 0.2% of all esophageal neoplasm. We report a case of primary spindle cell malignant melanoma of esophagus in a 69-year-old male who presented with history of dysphagia since 1 month. Radiological examinations revealed polypoidal growth at lateral aspect of esophagus. Biopsy was reported as grade III squamous cell carcinoma. Video assisted thoracoscopic esophagectomy was performed. Histopathological examination along with immunohistochemistry gave confirmed diagnosis of primary spindle cell malignant melanoma of esophagus. Though a rare entity, due to its aggressive nature and poor prognosis primary malignant melanoma should be one of the differential diagnoses in a patient with polypoidal esophageal mass lesion. Despite radical surgical treatment prognosis is extremely poor.

Helicobacter pylori Associated Gastritis in Northern Maharashtra, India: A Histopathological Study of Gastric Mucosal Biopsies.

INTRODUCTION: Helicobacter pylori (H.pylori) are of major concern today because of its causal relationships with gastrointestinal diseases. It represents one of the most common and medically important infections worldwide. H.pylori plays a key role in the aetiology of chronic gastritis, duodenal ulcer, gastric carcinoma and MALT lymphoma. There is paucity of literature regarding the morphological changes in H.pylori associated gastritis. AIM: We undertake this study to find out the association and prevalence of H.pylori associated gastritis by histopathological methods in North Maharashtra, India. MATERIALS AND METHODS: A total 310 patients with various upper gastrointestinal disorders were included in this study over the period of 19 months from July 2013 to January 2015. The detailed clinical history was taken and patients were subjected to video gastroscopy. Each biopsy was studied with Haematoxylin and Eosin/Giemsa method. RESULTS: The prevalence of H.pylori was high in third to fourth decades. Out of 310 patients of gastrocopy, 144 were H.pylori positive by Haematoxylin and Eosin/Giemsa method. Morphological changes specific for H.pylori was noted as atrophy and irregular gastric mucosa, lymphoid aggregates and reactive atypia. Male patient were outnumbered by female patients. CONCLUSION: Histopathological evaluation is the gold standard for diagnosing H.pylori infection. Prevalence of H.pylori in the present study was 46.5% in patients undergoing videogastroscopic biopsies for gastritis and vague upper gastrointestinal symptoms. Furthermore and large scale studies are required to establish the diagnostic modalities for H.pylori associated gastritis to prevent morbidity and mortality.

Cytodiagnosis of isolated primary hydatid cyst of breast masquerading as a breast neoplasm: A rare case report.

Hydatid cyst in the breast is very rare and unusual for its location. Reported incidence of hydatid cyst in the breast is 0.27% in the literature. Herein, we report a case of hydatid cyst of breast in a 65-year-old female who presented with painless, slowly growing lump in the breast mimicking breast neoplasm clinically. Radiological investigations such as ultrasonography and mammography may be helpful but not conclusive. Preoperative fine-needle aspiration cytology (FNAC) diagnosis was consistent with hydatid cyst of breast and was without any complications. Histopathological examination of lumpectomy specimen confirmed the diagnosis of hydatid cyst of breast. High suspicion of this entity should be there in the differential diagnosis in the evaluation of breast lump in endemic as well as in migrant population in nonendemic areas.

Gastrointestinal stromal tumour of small intestine presenting as a mesenteric mass.

Gastrointestinal stromal tumors (GISTs) are uncommon tumors; accounts for 0.1% to 3% of all gastrointestinal neoplasm. Most common site of involvement is stomach (60-70 %), small intestine (20-30 %) and rarely at extra-gastrointestinal sites like omentum and mesentery called as extra-gastrointestinal stromal tumor (EGIST). Diagnosis is based on characteristic histological findings and expression of transmembrane receptor tyrosine kinase protein (CD 117) derived from activated c-kit gene. Herein, we report a case of GIST of small intestine presented as mesenteric mass in a 35- year-old female and discuss review of literature.

Primary intratesticular pleomorphic leiomyosarcoma: a rare case report.

Intratesticular leiomyosarcoma is an extremely rare tumor of the genitourinary system. We report a case of intratesticular pleomorphic leiomyosarcoma in a 68-year-old male who presented with gradual painless enlargement of the right scrotal mass over a period of 1-2 years. Radiological examination revealed a right testicular tumor.Right radical orchiectomy was performed with high ligation of the spermatic cord. Histopathological examination along with immunohistochemistry confirmed the diagnosis of a pleomorphic leiomyosarcoma of the testis. This is, to the best of our knowledge, the 13 th case of primary intratesticular leiomyosarcoma and the third case of high-grade (pleomorphic) intratesticular leiomyosarcoma in an elderly male reported in the literature.

Clinicopathological Spectrum of Endometrial Changes in Peri-menopausal and Post-menopausal Abnormal Uterine Bleeding: A 2 Years Study.

BACKGROUND: Abnormal uterine bleeding is the Common presenting complaint in Gynaecology Outpatient Department in all age groups. It is due to the anovulatory cycles which are commonly seen in adolescent and peri-menopausal women. Abnormal uterine bleeding is caused by wide variety of organic or non-organic causes. Histopathological examination of endometrial sample remains the gold standard for diagnosis of endometrial pathology. AIM: To study the clinicopathological spectrum of endometrium in abnormal uterine bleeding in peri-menopausal and post-menopausal age groups. MATERIAL AND METHODS: The study included prospective analysis of 119 cases of endometrial samples in patients of abnormal uterine bleeding above 40 years of age. The specimens were routinely processed and H&E stained slides were studied. Patients were categorized into peri-menopausal (40-49 years) and post-menopausal (> 50 years) age group. RESULTS: A total of 119 specimens of endometrium were analyzed. Maximum number (73.94%) of cases were from peri-menopausal age group. The most common presenting complaint was menorrhagia (48.86%) followed by post-menopausal bleeding (26.05%). In peri-menopausal age group proliferative endometrium (35.22%) was the predominant histopathological pattern followed by endometrial hyperplasia (23.86%). Atrophic endometrium (25.80%) was the most frequent finding followed by endometrial hyperplasia (19.35%) in post-menopausal age group. Three cases of endometrial carcinoma were reported in post-menopausal age group only. CONCLUSION: A thorough histopathological work up and clinical correlation is mandatory in cases of abnormal uterine bleeding above the age of 40 years to find out organic lesions. Careful screening can detect early cancer of endometrium which has excellent prognosis and it will help in further management.